High-Grade Glioma (HGG)Phase 1TARLAGLIANCT07788677
Tarlatamab Treatment Before and After Surgery in Surgically Resectable Recurrent High-grade Glioma: a Window of Opportunity Study (TARLAGLIA Study)
A Phase 1 study testing Tarlatamab in people with High-Grade Glioma (HGG), run by Vall d'Hebron Institute of Oncology at 1 site in Spain.
Trial summary
This is a single-arm, window-of-opportunity clinical study evaluating tarlatamab administered before and after surgery in adult participants with surgically resectable recurrent DLL3-positive high-grade glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-Grade Glioma (HGG)
- What is being tested?
- Tarlatamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2026to 1 May 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Ability to provide written informed consent.
- Histologically confirmed diagnosis of DLL3 positive high-grade glioma (HGG).
- Candidate for neurosurgical resection of HGG, either in the category of supramaximal contrast-enhancing (CE) resection (class 1), maximal CE resection (class 2), or submaximal CE resection (class 3), according to the RANO resect group classification system for extent of resection (EOR).
- Surgery can be safely delayed for a minimum of 2 weeks following the Day 15 (D15) administration of study immunotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Show all 14Show fewer
- Adequate organ function, defined as follows:
- Hematological function: i. Absolute neutrophil count ≥ 1.5 x 109/L ii. Platelet count ≥ 100 x 109/L iii. Hemoglobin ≥ 9 g/dL (90 g/L) b. Coagulation function: i. prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 x institutional upper limit of normal (ULN) except for patients receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to study entry.
- Renal function: i. Estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculation > 30 mL/min/1.73 m2.
- Hepatic function: i. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN (or < 5 x ULN for patients with liver involvement).
- total bilirubin (TBL) < 1.5 x ULN (or < 2 x ULN for patients with liver involvement), except for patients with Gilbert's disease.
- Pulmonary function i. No oxygen supplementation. f. Cardiac function i. cardiac ejection fraction >/= 50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) finding.
- For women of childbearing potential: negative pregnancy test at screening.
- Willingness to use highly effective contraception during treatment during treatment and for at least 60 days after the last dose of tarlatamab,
Who cannot join
- Candidate for biopsy only (class 4), according to the RANO resect group classification system for EOR.
- Ongoing steroid treatment at a dose >4 mg dexamethasone equivalents daily.
- Active autoimmune disease that has required systemic treatment in the past 2 years (including disease-modifying agents, corticosteroids, or immunosuppressive drugs).
- Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is permitted.
- Known history of human immunodeficiency virus (HIV) infection (HIV-1/2 antibodies).
- Known active hepatitis B virus infection (hepatitis B surface antigen reactive).
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- Known active hepatitis C virus infection (HCV RNA qualitative positive).
- Receipt of a live vaccine or live-attenuated vaccine within 30 days before the first dose of study treatment.
- Prior malignancy within the past 3 years, except: except basal cell carcinoma or scaly skin, cervical carcinoma in situ adequately treated or other tumors treated curatively without recurrence for 3 or more years,
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Universitari Vall D Hebron
Barcelona, Catalonia, 08035
María Vieito, Dr, +34932746085, mvieito@vhio.net
About this study
This is a single-arm, window-of-opportunity clinical study evaluating tarlatamab administered before and after surgery in adult participants with surgically resectable recurrent DLL3-positive high-grade glioma. The study is designed to assess the feasibility and safety of neoadjuvant tarlatamab treatment prior to planned tumor resection, as well as the safety and tolerability of postoperative adjuvant tarlatamab.
Eligible participants will have histologically confirmed recurrent high-grade glioma with DLL3-positive tumor expression and will be candidates for neurosurgical resection in whom surgery can be safely delayed to allow neoadjuvant treatment. Participants will receive tarlatamab intravenously using a step-up dosing regimen during the neoadjuvant phase, followed by planned surgical resection after a washout period. After recovery from surgery, participants will restart tarlatamab with step-up dosing and continue adjuvant treatment every 2 weeks for up to 6 cycles.
Read more
The primary objective is to evaluate the feasibility and safety of neoadjuvant tarlatamab, including the number of participants able to complete the dose-limiting toxicity evaluation period and undergo planned surgery without experiencing a dose-limiting toxicity. Safety assessments will include adverse events graded according to CTCAE v5.0, as well as cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome graded according to ASTCT criteria.
Secondary objectives include assessment of antitumor activity using RANO and iRANO criteria, progression-free survival, 12-month overall survival, quality of life using EORTC QLQ-C30 and EORTC QLQ-BN20 questionnaires, and the incidence, severity, and type of treatment-emergent adverse events during the adjuvant treatment period.
- Conditions
- High-Grade Glioma (HGG)
- Being tested
- Tarlatamab
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TarlatamabBiological
Tarlatamab will be administered by intravenous infusion using a step-up dosing regimen. During the neoadjuvant phase, participants will receive 1 mg on Cycle 1 Day 1, followed by 10 mg on Cycle 1 Day 8 and Day 15. Surgery will be performed after a 2-week washout period following the Day 15 dose. Postoperatively, tarlatamab will be restarted approximately 3 weeks after surgery using step-up dosing with 1 mg on Day 1, followed by 10 mg on Day 8 and Day 15. Thereafter, participants will receive tarlatamab 10 mg intravenously every 2 weeks for up to 6 cycles. Each treatment cycle is defined as 4 weeks. Tarlatamab will be administered as a 60-minute intravenous infusion, followed by a slow bolus flush.
| Study group | Role | What they receive |
|---|---|---|
| Recurrent high-grade glioma with DDL-3 positive tumor expression, as assessed by IHC. | Experimental | Participants with surgically resectable recurrent DLL3-positive high-grade glioma will receive neoadjuvant tarlatamab prior to planned surgery, followed by adjuvant tarlatamab after surgery. In the neoadjuvant phase, tarlatamab will be administered intravenously using a step-up regimen of 1 mg on Cycle 1 Day 1, followed by 10 mg on Days 8 and 15. Surgery will be performed after a 2-week washout period following the Day 15 dose. Approximately 3 weeks after surgery, tarlatamab will be restarted with step-up dosing of 1 mg on Day 1, followed by 10 mg on Days 8 and 15, then continued at 10 mg intravenously every 2 weeks for up to 6 cycles, with each cycle defined as 4 weeks. Receives: Biological: Tarlatamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Completing the DLT Evaluation Period and Undergoing Planned Surgery Without a DLT
Number of participants who complete the protocol-defined DLT evaluation period and undergo the planned surgical resection without experiencing a DLT. A participant will be counted only if all criteria are met. DLTs are defined according to protocol-specified criteria.
Measured: From first neoadjuvant tarlatamab dose through the postoperative safety assessment 7 days after surgery; Cycle 1 is 4 weeks, with dosing on Days 1, 8, and 15 and surgery approximately 2 weeks after Day 15.
Number of Participants With Treatment-Emergent Adverse Events
Number of participants with at least one treatment-emergent adverse event (TEAE). AEs will be coded using MedDRA and severity graded according to NCI CTCAE v5.0, except CRS and ICANS, which will be graded according to ASTCT consensus criteria.
Measured: From first study intervention through 60 days after cessation of study intervention.
Number of Participants With Treatment-Related Adverse Events
Number of participants with at least one adverse event assessed as related to study intervention. AEs will be coded using MedDRA and severity graded according to NCI CTCAE v5.0, except CRS and ICANS, which will be graded according to ASTCT consensus criteria.
Measured: From first study intervention through 60 days after cessation of study intervention.
Incidence of all treatment-emergent adverse events and treatment-related adverse events.
Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs) and treatment-related adverse events during the study. Events will be summarized by incidence, type, severity, seriousness, and relationship to tarlatamab.
Measured: From first study intervention through 60 days after cessation of study intervention.
Number of Participants With Cytokine Release Syndrome by Maximum ASTCT Grade
Number of participants with cytokine release syndrome (CRS), categorized according to the maximum CRS grade experienced during the assessment period using the ASTCT consensus grading criteria.
Measured: From first study intervention through 60 days after cessation of study intervention.
Number of Participants With ICANS by Maximum ASTCT Grade
Number of participants with immune effector cell-associated neurotoxicity syndrome (ICANS), categorized according to the maximum ICANS grade experienced during the assessment period using the ASTCT consensus grading criteria.
Measured: From first study intervention through 60 days after cessation of study intervention.
Secondary outcomes (6)
Response rate according to RANO and iRANO criteria.
Percentage of participants achieving a complete response (CR) or partial response (PR) according to RANO and iRANO criteria, as assessed by the investigator using serial MRI examinations.
Measured: From treatment initiation; MRI at baseline, pre-surgery, and every 8 weeks thereafter until end of treatment or disease progression, assessed up to approximately 7 months.
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from treatment initiation to the first documented disease progression according to RANO/iRANO criteria or death from any cause, whichever occurs first.
Measured: From treatment initiation to the first documented disease progression per RANO/iRANO criteria or death from any cause, whichever occurs first, assessed up to 24 months.
Overall survival (OS)
Overall survival (OS) is defined as the time from treatment initiation to death from any cause. Participants alive at the time of analysis will be censored at the last date they were known to be alive.
Measured: From treatment initiation until death from any cause, assessed up to 12 months.
EORTC QLQ-C30 questionnaires.
Assessment of health-related quality of life using the 30-item EORTC QLQ-C30 questionnaire. Scores will be calculated according to the published EORTC scoring guidelines to assess global health status, functioning, and cancer-related symptoms.
Measured: Baseline, after surgery, and every 3 months thereafter through end of treatment or disease progression.
EORTC QLQ-BN20 questionnaires
Assessment of brain tumor-specific symptoms and functioning using the 20-item EORTC QLQ-BN20 questionnaire. Scores will be calculated according to the published EORTC scoring guidelines to assess brain tumor-related symptoms and functional impairment.
Measured: Baseline, after surgery, and every 3 months thereafter through end of treatment or disease progression.
Incidence, severity (graded per CTCAE v5.0 and ASTCT criteria for CRS and ICANS), and type of treatment-emergent adverse events occurring during the adjuvant treatment period.
Assessment of treatment-emergent adverse events during adjuvant tarlatamab treatment. Events will be summarized by incidence, type, and severity. Severity will be graded using CTCAE v5.0, except CRS and ICANS, which will be graded using ASTCT criteria.
Measured: From first postoperative adjuvant tarlatamab dose through 60 days after completion of adjuvant treatment; up to 6 cycles (each cycle is 4 weeks), for an estimated total of approximately 33 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Grade Glioma (HGG)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vall d'Hebron Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788677
- Sponsor's protocol ID
- VHIO25001
- Other IDs
- 2025-524359-30-00, 2025
- Acronym
- TARLAGLIA
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tarlatamab Treatment Before and After Surgery in Surgically Resectable Recurrent High-grade Glioma: a Window of Opportunity Study (TARLAGLIA Study)
- ClinicalTrials.gov ID
- NCT07788677
- Acronym / sponsor ID
- TARLAGLIA / VHIO25001
- Conditions
- High-Grade Glioma (HGG)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Vall d'Hebron Institute of OncologyUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm, window-of-opportunity clinical study evaluating tarlatamab administered before and after surgery in adult participants with surgically resectable recurrent DLL3-positive high-grade glioma. The study is designed to assess the feasibility and safety of neoadjuvant tarlatamab treatment prior to planned tumor resection, as well as the safety and tolerability of postoperative adjuvant tarlatamab.
Eligible participants will have histologically confirmed recurrent high-grade glioma with DLL3-positive tumor expression and will be candidates for neurosurgical resection in whom surgery can be safely delayed to allow neoadjuvant treatment. Participants will receive tarlatamab intravenously using a step-up dosing regimen during the neoadjuvant phase, followed by planned surgical resection after a washout period. After recovery from surgery, participants will restart tarlatamab with step-up dosing and continue adjuvant treatment every 2 weeks for up to 6 cycles.
The primary objective is to evaluate the feasibility and safety of neoadjuvant tarlatamab, including the number of participants able to complete the dose-limiting toxicity evaluation period and undergo planned surgery without experiencing a dose-limiting toxicity. Safety assessments will include adverse events graded according to CTCAE v5.0, as well as cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome graded according to ASTCT criteria.
Secondary objectives include assessment of antitumor activity using RANO and iRANO criteria, progression-free survival, 12-month overall survival, quality of life using EORTC QLQ-C30 and EORTC QLQ-BN20 questionnaires, and the incidence, severity, and type of treatment-emergent adverse events during the adjuvant treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recurrent high-grade glioma with DDL-3 positive tumor expression, as assessed by IHC. | Experimental | Biological: TarlatamabParticipants with surgically resectable recurrent DLL3-positive high-grade glioma will receive neoadjuvant tarlatamab prior to planned surgery, followed by adjuvant tarlatamab after surgery. In the neoadjuvant phase, tarlatamab will be administered intravenously using a step-up regimen of 1 mg on Cycle 1 Day 1, followed by 10 mg on Days 8 and 15. Surgery will be performed after a 2-week washout period following the Day 15 dose. Approximately 3 weeks after surgery, tarlatamab will be restarted with step-up dosing of 1 mg on Day 1, followed by 10 mg on Days 8 and 15, then continued at 10 mg intravenously every 2 weeks for up to 6 cycles, with each cycle defined as 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥18 years.
- Ability to provide written informed consent.
- Histologically confirmed diagnosis of DLL3 positive high-grade glioma (HGG).
- Candidate for neurosurgical resection of HGG, either in the category of supramaximal contrast-enhancing (CE) resection (class 1), maximal CE resection (class 2), or submaximal CE resection (class 3), according to the RANO resect group classification system for extent of resection (EOR).
- Surgery can be safely delayed for a minimum of 2 weeks following the Day 15 (D15) administration of study immunotherapy.
Key exclusion criteria (10 listed)
- Candidate for biopsy only (class 4), according to the RANO resect group classification system for EOR.
- Ongoing steroid treatment at a dose >4 mg dexamethasone equivalents daily.
- Active autoimmune disease that has required systemic treatment in the past 2 years (including disease-modifying agents, corticosteroids, or immunosuppressive drugs).
- Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is permitted.
- Known history of human immunodeficiency virus (HIV) infection (HIV-1/2 antibodies).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TarlatamabTarlatamab will be administered by intravenous infusion using a step-up dosing regimen. During the neoadjuvant phase, participants will receive 1 mg on Cycle 1 Day 1, followed by 10 mg on Cycle 1 Day 8 and Day 15. Surgery will be performed after a 2-week washout period following the Day 15 dose. Postoperatively, tarlatamab will be restarted approximately 3 weeks after surgery using step-up dosing with 1 mg on Day 1, followed by 10 mg on Day 8 and Day 15. Thereafter, participants will receive tarlatamab 10 mg intravenously every 2 weeks for up to 6 cycles. Each treatment cycle is defined as 4 weeks. Tarlatamab will be administered as a 60-minute intravenous infusion, followed by a slow bolus flush. | Biological | Recurrent high-grade glioma with DDL-3 positive tumor expression, as assessed by IHC. |
Primary outcome
Number of Participants Completing the DLT Evaluation Period and Undergoing Planned Surgery Without a DLT
Time frame: From first neoadjuvant tarlatamab dose through the postoperative safety assessment 7 days after surgery; Cycle 1 is 4 weeks, with dosing on Days 1, 8, and 15 and surgery approximately 2 weeks after Day 15.
Number of participants who complete the protocol-defined DLT evaluation period and undergo the planned surgical resection without experiencing a DLT. A participant will be counted only if all criteria are met. DLTs are defined according to protocol-specified criteria.
Number of Participants With Treatment-Emergent Adverse Events
Time frame: From first study intervention through 60 days after cessation of study intervention.
Number of participants with at least one treatment-emergent adverse event (TEAE). AEs will be coded using MedDRA and severity graded according to NCI CTCAE v5.0, except CRS and ICANS, which will be graded according to ASTCT consensus criteria.
Number of Participants With Treatment-Related Adverse Events
Time frame: From first study intervention through 60 days after cessation of study intervention.
Number of participants with at least one adverse event assessed as related to study intervention. AEs will be coded using MedDRA and severity graded according to NCI CTCAE v5.0, except CRS and ICANS, which will be graded according to ASTCT consensus criteria.
Incidence of all treatment-emergent adverse events and treatment-related adverse events.
Time frame: From first study intervention through 60 days after cessation of study intervention.
Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs) and treatment-related adverse events during the study. Events will be summarized by incidence, type, severity, seriousness, and relationship to tarlatamab.
Number of Participants With Cytokine Release Syndrome by Maximum ASTCT Grade
Time frame: From first study intervention through 60 days after cessation of study intervention.
Number of participants with cytokine release syndrome (CRS), categorized according to the maximum CRS grade experienced during the assessment period using the ASTCT consensus grading criteria.
Number of Participants With ICANS by Maximum ASTCT Grade
Time frame: From first study intervention through 60 days after cessation of study intervention.
Number of participants with immune effector cell-associated neurotoxicity syndrome (ICANS), categorized according to the maximum ICANS grade experienced during the assessment period using the ASTCT consensus grading criteria.
6 secondary outcomes
Response rate according to RANO and iRANO criteria.
Time frame: From treatment initiation; MRI at baseline, pre-surgery, and every 8 weeks thereafter until end of treatment or disease progression, assessed up to approximately 7 months.
Progression-free survival (PFS)
Time frame: From treatment initiation to the first documented disease progression per RANO/iRANO criteria or death from any cause, whichever occurs first, assessed up to 24 months.
Overall survival (OS)
Time frame: From treatment initiation until death from any cause, assessed up to 12 months.
EORTC QLQ-C30 questionnaires.
Time frame: Baseline, after surgery, and every 3 months thereafter through end of treatment or disease progression.
EORTC QLQ-BN20 questionnaires
Time frame: Baseline, after surgery, and every 3 months thereafter through end of treatment or disease progression.
Incidence, severity (graded per CTCAE v5.0 and ASTCT criteria for CRS and ICANS), and type of treatment-emergent adverse events occurring during the adjuvant treatment period.
Time frame: From first postoperative adjuvant tarlatamab dose through 60 days after completion of adjuvant treatment; up to 6 cycles (each cycle is 4 weeks), for an estimated total of approximately 33 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tarlatamab in people with High-Grade Glioma (HGG), run by Vall d'Hebron Institute of Oncology at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Completing the DLT Evaluation Period and Undergoing Planned Surgery Without a DLT (time frame: From first neoadjuvant tarlatamab dose through the postoperative safety assessment 7 days after surgery; Cycle 1 is 4 weeks, with dosing on Days 1, 8, and 15 and surgery approximately 2 weeks after Day 15.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.